MAUDE Adverse Event Report: MICROPORT CRM S.R.L. KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 100 DR

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

The pacing system was implanted on (b)(6) 2016.Reportedly, the pacemaker reached its recommended replacement time (rrt) after less than 5 years.The pacemaker was explanted on (b)(6) 2021.Preliminary analysis revealed, that, based on available data, normal battery depletion occurred (based on hrs guidelines).

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The pacing system was implanted on (b)(6) 2016.Reportedly, the pacemaker reached its recommended replacement time (rrt) after less than 5 years.The pacemaker was explanted on (b)(6) 2021.Preliminary analysis revealed, that, based on available data, normal battery depletion occurred (based on hrs guidelines).

Event Description

The pacing system was implanted on (b)(6) 2016.Reportedly, the pacemaker reached its recommended replacement time (rrt) after less than 5 years.The pacemaker was explanted on (b)(6) 2021.Preliminary analysis revealed, that, based on available data, normal battery depletion occurred (based on hrs guidelines).

Manufacturer Narrative

Electrical characteristics of the returned device were within specifications.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11347312
• MDR Text Key: 234048475
• Report Number: 1000165971-2021-00296
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012711
• UDI-Public: (01)08031527012711(11)150317(17)161017
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2016
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0071
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/25/2021; 03/19/2021
• Supplement Dates FDA Received: 02/26/2021; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1